Friedmund Bachmann

Vice President CMC
​​OncoOne Research & Development GmbH

Friedmund Bachmann serves as Vice President CMC and project lead for the Oncology program ON203 at OncoOne. OncoOne, is a Vienna-based biotech company, founded in 2018 and is dedicated to the development of novel therapeutics for patients living with chronic inflammatory diseases and solid tumors.

Friedmund became a part of the OncoOne team in 2021, consistently demonstrating outstanding leadership skills and leveraging his extensive knowledge to enhance our CMC department. In addition he is driving the cross functional development of OncoOne’s oncology program ON203, an anti-oxMIF antibody for the treatment of solid tumor indication to enter clinical Phase 1 in end of 2024.

Friedmund rich experience spanning over two decades with exceptional expertise spanning diverse domains including Business Development, R&D, Project and Program Management, Alliance Management, CMC Regulatory, Manufacturing, and Quality Assurance with key focus on complex biologics CMC management across all different stages of development until commercialization, showcasing his deep comprehension of the value chain for biological products. 

Prior to his current role, he held various positions with ascending levels of responsibility within Pharmaceutical Sciences, CMC development, and CMC operations. His track record includes successful leadership of CMC programs encompassing the complete life cycle, spanning early-stage, late-stage, and commercial development for vaccines and products within oncology, hematology, and inflammatory diseases at prominent companies such as Baxter, Baxalta, Shire, and Takeda.

Speech title & Synopsis

Decoding CMC Program Design: Unveiling the Blueprint for Success in Biologics Development

In the lifecycle of biologic therapeutics products Chemistry, Manufacturing, and Controls (CMC) is a pivotal element ensuring consistent safety, efficacy, and quality of products. Given the complex and highly regulated nature of the pharmaceutical industry, the establishment of a robust CMC development roadmap is critical for the progression from discovery into clinical trials and beyond. Such robust development strategy ultimately leads to lower probability of technical and regulatory success (PTRS) and removes bottlenecks in the supply chain.

Even more critical is this element for small biotech companies as they also need to navigate through additional challenges such as limited funding, resource constraints, as well as to fulfil requirements from big pharmaceutical companies as partners for co-development or licensing.
The talk will focus on strategic planning and implementation of CMC processes tailored for early-stage development in small enterprises. Critical aspects such as material selection, process design, or product control for cost-effective but at the same time compliant production will be discussed. Next to technical and commercial considerations the talk will emphasize the importance of early and continuous engagement with regulatory agencies to ensure alignment with applicable guidelines as well as expectations.

For illustration of a successfully implemented CMC strategy the approach OncoOne has undertaken for their ON203 mAb program is presented.
Attendees will gain valuable insights into practical approaches for optimizing CMC programs, which are crucial for the successful transition from early development to clinical trials and eventual commercialization.